As US biosimilar activity rises, is the first filing imminent?
This article was originally published in Scrip
Executive Summary
With the launch of biosimilar Remicade marking another reference point in Europe's expanding biosimilars landscape, the question arises: When can we expect the first biosimilar filing in the US? No one's saying, but the steady rise in sponsor-FDA activity over the past few years suggests it may not be long now.
You may also be interested in...
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.
Denmark Planning To Impose Drug Stockpiling Obligations From July
A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.
National Drug Stockpiles Create ‘False Sense Of Security’
The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.